Balanced propofol sedation for therapeutic GI endoscopic procedures: a prospective, randomized study

Background: There are few controlled studies on balanced propofol sedation (BPS) for therapeutic endoscopy.

Objective: To compare the safety and efficacy of BPS (propofol in combination with midazolam and meperidine) with conventional sedation (midazolam and meperidine) in patients undergoing therapeutic endoscopic procedures.

Design: Prospective, randomized, single-blinded study.

Setting: Tertiary-care referral center.

Patients: This study involved 222 consecutive patients undergoing therapeutic EGD or ERCP from July 2009 to March 2010.

Intervention: Conventional sedation or BPS by trained registered nurses under endoscopist supervision.

Main outcome measurements: Rates of sedation-related cardiopulmonary complications and interruption of the procedures, procedure-related times, and assessments of health care providers (endoscopists and sedation nurses) and patients.

Results: There were no significant differences between the BPS and conventional groups in the rates of cardiopulmonary complications (8.8% [9/102] vs 5.8% [6/104], respectively) and transient interruption of procedures (2.9% [3/102] vs 0% [0/104], respectively). No patient required assisted ventilation or premature termination of a procedure. BPS provided significantly higher health care provider satisfaction (mean±SD 10-cm visual analog scale [VAS] score) compared with conventional sedation (endoscopists: 7.57±2.61 vs 6.55±2.99, respectively; P=.011; sedation nurses: 7.86±2.31 vs 6.67±2.90, respectively; P=.001). Patient cooperation was significantly better in the BPS group (VAS; endoscopists: 7.24±2.97 vs 6.27±3.09, P=.024; sedation nurses: 7.75±2.30 vs 6.54±2.99, P=.001).

Limitations: Single-center and single-blinded study.

Conclusion: Compared with conventional sedation, BPS provides higher health care provider satisfaction, better patient cooperation, and similar adverse event profiles in patients undergoing therapeutic endoscopic procedures.